The creation of an ostomy (stoma) is the therapy for many sufferers of diseases or injury of the gastrointestinal or urinary tract. An ostomy is the rerouting of the tract through the abdominal wall to outside the patient's body. Once a stoma has been created, the patient must, usually for the rest of his or her life, use a device worn on the body for capturing or containing the body waste. This has traditionally been done with a bag or pouch attached to the body with adhesive patches or constricting belts. However, the wearing of such a pouch may be an embarrassing experience for many ostomates. A pouch may require changes in an ostomate's activities.
A stoma closure offers the potential for an ostomate to return to some form of normality. The closure is used to block the stoma, in order to store body waste temporarily inside the tract. The closure is removable manually when the ostomate desires to discharge the body waste.
However, it is difficult to design a stoma closure that can combine user friendliness and patient comfort with a high sealing performance. Seal performance is extremely important, in order to spare the ostomate the leakage of body waste. The seal also has to be able to withstand motion of the body without leaking. Yet, at the same time, the closure should be easy for the ostomate to apply and use, be comfortable to wear, and avoid damage to the highly sensitive stoma tissue.
U.S. Pat. Nos. 4,941,869; 4,981,465; and 4,344,434 describe stoma closures in the form of expanding foam plugs insertable into the stoma. However, it is believed that none of the above devices has enjoyed high patient acceptance, because the devices fail to satisfy the high personal requirements of ostomates as explained above.